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FDA Delays in Response to Rulemaking Petitions

By Lou Caputo

The Administrative Procedure Act sets out the general process for rulemaking for federal agencies. 5 U.S.C.A. § 553 (West).  Under the rule, any “interested person” may petition for the “issuance, amendment, or repeal of a rule.” 5 U.S.C.A. § 553(e) (West).  The Act requires agencies to issue “prompt notice” when they deny such a petition, and that such notice include a brief explanation for the denial. 5 U.S.C.A. § 555(e) (West).  There is no specific time limit in which an agency has to issue a decision.  Instead, the Act offers in consolation that, “With due regard for the convenience and necessity of the parties or their representatives and within a reasonable time, each agency shall proceed to conclude a matter presented to it.” 5 U.S.C.A. § 555 (West).

Congress can provide parameters for an agency’s rulemaking process through direct legislation, or it can simply allow the agency to craft the procedure itself through regulations.  See e.g. Food, Drug, and Cosmetic Act (FDCA), Section 409(c)(2) (setting a limit of between 90-180 days for the FDA to respond to certain petitions concerning food additives).  Under the FDCA, Congress initially required the FDA to develop a comprehensive plan for, among other things: “maximizing the availability and clarity of information about the process for review of …petitions; establishing mechanisms… for meeting the time periods specified in this chapter for the review of all [petitions]; and eliminating backlogs in the review of [petitions].” 21 U.S.C.A. § 393 (West).  The FDCA gives general rulemaking authority to the Dept. of Health and Human Services. 21 U.S.C.A. § 371 (West).  Such authority is implemented through various regulations, which are delineated in Title 21 of the Code of Federal Regulations (CFR).

When answering any petition, the FDA must take into account three factors: (1) available agency resources for the category of subject matter; (2) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency; and (3) time requirements established by statute. 21 C.F.R. § 10.30 (e)(1).  There is a 180-day time limit written into the regulation by which time the FDA should respond; however, this response does not have to provide a definitive answer to the issue raised in the petition.  It is sufficient for FDA merely to inform the petitioner that the agency “hasn’t been able to get to it” (“e.g., because of the existence of other agency priorities, or a need for additional information”).  The FDA may, but is not required to, indicate the likely ultimate agency response or forecast when a final response will be furnished. 21 C.F.R. § 10.30(e)(3).  The non-responsive, resource insufficiency, answer has been upheld as a sufficient response. See In re Natural Resources Defense Counsel (NRDC), 645 F.3d 400 (D.C. App. 2011) (explaining that, “section § 10.30(e)(1) does nothing more than make the statutory deadlines one of several factors that the FDA must consider and weigh in its discretion”).

The FTC also allows for citizen rulemaking petitions, but its regulations impose no time limits. 16 C.F.R. § 1.9.  The Federal Communications Commission follows suit, simply saying that it “may act on a petition for rule making at any time after the deadline for the filing of replies to statements in support of or in opposition to the petition.” 47 C.F.R. § 1.405.  The problem is immediately evident: how does one ever successfully overcome subjective factors such as agency “resources” and “priority?”  The most likely answer would seem to be through court action.

The Administrative Procedures Act does provide for a court to step in and compel an agency to make a decision if such response has been unlawfully “withheld or unreasonably delayed.” 5 U.S.C.A. § 706 (West).  Of course, that language is about as helpful to a petitioner as the FDA regulations themselves.  What constitutes unreasonable delay is governed by six factors (besides a matter of opinion): (1) the time agencies take to make decisions must be governed by a “rule of reason”; (2) where Congress has provided a timetable or other indication of the speed with which it expects the agency to proceed in the enabling statute, that statutory scheme may supply content for this rule of reason; (3) delays that might be reasonable in the sphere of economic regulation are less tolerable when human health and welfare are at stake; (4) the court should consider the effect of expediting delayed action on agency activities of a higher or competing priority; (5) the court should also take into account the nature and extent of the interests prejudiced by delay; and (6) the court need not “find any impropriety lurking behind agency lassitude in order to hold that agency action is ‘unreasonably delayed.’” Telecommunications Research & Action Ctr. (TRAC) v. F.C.C., 750 F.2d 70, 80 (D.C. Cir. 1984) (internal citations omitted).

To compel agency action, including a substantive response to a petition for rulemaking, interested parties may file a “writ of mandamus” to have a federal court order the FDA to act.  “Mandamus is an extraordinary remedy reserved for extraordinary circumstances.” In re Am. Rivers & Idaho Rivers United, 372 F.3d 413, 418 (D.C. Cir. 2004).

Even when you win the fight for a mandamus, you can still lose.  In In re United Mine Workers of Am. Int’l Union, 190 F.3d 545, 546 (D.C. Cir. 1999), the plaintiffs, United Mine Workers of America (UMWA), filed for a writ of mandamus to force the Mine Safety and Health Administration (MSHA) to issue final regulations concerning diesel engine gas emissions in underground coal mines.  In 1983, the MSHA completed the record for new regulations concerning underground mine air quality standards, yet even eight years later never issued a final ruling.  Looking to limits imposed by statute, the court found that the MSHA had violated the time limit imposed by the Mine Act, which was 90 days after the certification of the hearing record or the close of the comment period if no hearing was necessary. In re United Mine Workers of Am. Int’l Union, 190 F.3d 545, 551 (D.C. Cir. 1999).  The Court, though, was not finished.  Using the TRAC factors, the court explained that, “We must…take care not to craft a remedy for MSHA’s statutory violation that could both interfere with the agency’s internal processes and damage the very interests the petitioner seeks to protect.” Id. at 553.  The court instead ordered the agency to produce a rulemaking schedule, finding that an appropriate remedy for the agency “to come into compliance with its statutory obligations.” Id at 555.

While United Mine Workers does not involve the FDA, it remains a good example of how the rulemaking process generally can be a slow one even following that rare instance when a court issues a mandamus order.  In the end, those who petition for modification, addition, or elimination of a rule must be prepared to wait for a response, sometimes for decades.  When taxed to the breaking point, a petitioner may seek judicial intervention but ordinarily cannot rely on the federal courts to compel federal agencies to act by a date certain.





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